Effects of phrenic nerve electrical stimulation on diaphragm function and weaning outcomes

Not Applicable

• Conditions: Patients with acute respiratory failure requiring invasive mechanical ventilation; Respiratory; Acute respiratory failure

• Registration Number: ISRCTN17616237
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 12 July 2021
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with acute respiratory failure requiring invasive mechanical ventilation
*Incorporated within 48 hours after the establishment of the artificial airway
2. Estimated mechanical ventilation time >72 hours
3. Aged over 18 years old

Exclusion Criteria

1. Pneumothorax or mediastinal emphysema
2. Acute myocarditis, severe arrhythmia
3. Neuromuscular diseases that may affect weaning, including myasthenia gravis, motor neuron disease, and congenital myopathy
4. Hemodynamic instability (mean arterial pressure <60 mmHg and norepinephrine >0.2 ug/kg/min)
5. Paroxysmal sympathetic hyperactivity syndrome
6. Even chest
7. Pregnancy
8. Fitted with a pacemaker/implantable defibrillator
9. Applying neuromuscular blockers (NMBAs) within the past 6 hours
10. History of neck radiation therapy or neck surgery
11. Cancer of the neck and lung
12. Unable to obtain accurate diaphragm ultrasound results

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Enrollment rate: number of enrolled patients divided by total number of patients meeting the criteria of this study at 48 hours after the establishment of an artificial airway<br> 2.Retention rate (incorporating acceptability of the therapy): number of patients who completed the study divided by number of patients admitted at the end of the entire experiment<br> 3. Response rate: diaphragmatic mobility measured by ultrasound at the first EDP treatment<br> 4. Incidence rate of adverse events measured using number of patients with adverse events divided by patients enrolled in the group during the entire test<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Diaphragm thickness: at the end of exhalation and inspiration the thickness of the right diaphragm will be measured using diaphragm ultrasound during tidal breathing to calculate the muscle thickening score. Measured at baseline, every other day, for the first SBT (under EDP) and on day 28<br> 2. Diaphragm mobility: right diaphragmatic mobility, inspiratory time, inspiratory slope and acceleration measured using diaphragm ultrasound at the first SBT (under EDP treatment)<br> 3. Duration of mechanical ventilation, reintubation, weaning success rate and survival rate measured using patient records within 28 days<br> 4. Blood gas analysis using blood gas analysis instrument before and after EDP session every morning<br>